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TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

3 mei 2013 bijgewerkt door: Tibotec Pharmaceuticals, Ireland

Photosensitivity Trial. A Randomized, Double-blind, Double Dummy, Placebo- and Positive Controlled Phase I Trial to Evaluate the Photosensitizing Potential of TMC435 in Healthy Subjects.

The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of the skin towards exposure to sunlight. TMC435 is a drug that is currently under development for treatment of chronic hepatitis C virus infection. This study will be conducted in healthy volunteers. Ciprofloxacin, a commonly used antibiotic, is used as a positive control as this drug is known to mildly increase skin sensitivity to exposure to sunlight. This study also evaluates the levels of TMC435 and ciprofloxacin in the blood circulation and the safety and tolerability of TMC435.

Studie Overzicht

Gedetailleerde beschrijving

This is a randomized (study drug assigned by chance), double blind (neither the study doctor, nor medical staff nor the healthy volunteer know the name of the assigned drug), double-dummy (all healthy volunteers take the same number of identically looking capsules, independent of the drug they have been assigned to), placebo- and positive-controlled (ciprofloxacin is a drug known to cause a mild photosensitive response) study. A total of 36 healthy volunteers will participate. Participants will be assigned to take TMC435 (one dose between 75 and 150 mg, once a day), TMC435-placebo (once a day) or ciprofloxacin (500 mg twice a day). The aim of this study is to look at the reaction of the skin after exposure to artificial sunlight when taking TMC435, ciprofloxacin or placebo. Study drug will be administered for 9 days. Phototesting (area of skin on your back will be exposed to artificial sunlight) will be conducted during 3 days before intake of study medication starts and during 3 days (Days 8, 9 and 10) during treatment. Skin reactions, general tolerability and safety of TMC435 will be assessed throughout the trial period (or longer if needed). Blood and urine samples will be taken at screening, on day 1, day 7, day 10 and at 2 follow-up visits. Blood levels of TMC435 and ciprofloxacin will be determined on Day 1, 5, 6, 7 (16 times), 8 (twice), 9 (twice) and 10. ECG and vital signs will be taken at screening, on day 1, twice on day 7, on day 10 and at 2 follow-up visits. A physical examination will be done at screening, on day 1, day 10 and at both follow-up visits. Volunteers assigned to the TMC435 group will receive a morning oral dose (dose between 75 and 150 mg) of TMC435 and a noon and evening oral dose of placebo, for 9 consecutive days. Volunteers assigned to the placebo group will receive oral placebo doses in the morning, at noon and in the evening, for 9 consecutive days. Volunteers assigned to the ciprofloxacin group will receive an oral morning placebo dose and a noon and evening oral dose of 500 mg ciprofloxacin, for 9 consecutive days.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

49

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Skin type I to III
  • No ultraviolet exposure on the back for 4 weeks prior to baseline phototesting
  • Normal skin response during baseline phototesting
  • Body Mass Index of 18.0 to 30.0 kg/m2
  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram.

Exclusion Criteria:

  • History of hypersensitivity to sunlight or artificial source of intense light, especially UV light
  • history or currently active porphyria or lupus erythematosus
  • Positive plasma porphyrin scan and lupus erythematosus antibodies
  • Active skin disorders on the back where phototesting will be performed
  • Infection with Hepatitis A, B or C virus
  • Infection with the human immunodeficiency virus (HIV)
  • Women who are pregnant or breastfeeding
  • History of or any current medical condition which could impact the safety of the participant in the study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 001
TMC435 one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening for 9 days
one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days
Placebo-vergelijker: 002
Placebo placebo dose in the morning at noon and in the evening for 9 days
placebo dose in the morning, at noon and in the evening, for 9 days
Actieve vergelijker: 003
Ciprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days
one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light
Tijdsspanne: Final phototesting assessment will be done on day 9 and 10 during medication intake.
Final phototesting assessment will be done on day 9 and 10 during medication intake.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Rate and extent of absorption of TMC435 and ciprofloxacin in the blood circulation
Tijdsspanne: Determined on Day1, 5, 6, 7, 8, 9 and 10, with extensive pharmacokinetic testing on Day7.
Determined on Day1, 5, 6, 7, 8, 9 and 10, with extensive pharmacokinetic testing on Day7.
Number of participants with Adverse Events as measures for Safety and Tolerability..
Tijdsspanne: Until last follow-up visit 30-35 days after last drug intake.
Until last follow-up visit 30-35 days after last drug intake.
Number of Adverse Events (per type) as measures for Safety and Tolerability.
Tijdsspanne: Until last follow-up visit 30-35 days after last drug intake.
Until last follow-up visit 30-35 days after last drug intake.
Results of clinical laboratory evaluations as measures for Safety and Tolerability.
Tijdsspanne: Until last follow-up visit 30-35 days after last drug intake.
Until last follow-up visit 30-35 days after last drug intake.
Vital signs including ECG monitoring as measures for Safety and Tolerability.
Tijdsspanne: Until last follow-up visit 30-35 days after last drug intake.
Until last follow-up visit 30-35 days after last drug intake.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2010

Primaire voltooiing (Werkelijk)

1 april 2011

Studie voltooiing (Werkelijk)

1 april 2011

Studieregistratiedata

Eerst ingediend

13 mei 2010

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2010

Eerst geplaatst (Schatting)

17 mei 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

6 mei 2013

Laatste update ingediend die voldeed aan QC-criteria

3 mei 2013

Laatst geverifieerd

1 mei 2013

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Hepatitis C-virus

Klinische onderzoeken op TMC435

3
Abonneren